Iroko Phase 3 pain drug study meets primary endpoint

The investigational drug has established a significant pain relief compared with placebo in the multi-centre study that randomized 462 patients with either submicron indomethacin, celecoxib or placebo.

Iroko chief medical officer Dr. Clarence Young said, "These top line results lend further support to our novel approach to developing new NSAID formulations that may be able to do more with less, a concept that could represent a significant new development in the area of pain management."

Pain relief measured was the combined differences in pain intensity assessed every 48 hours using a visual analog scale (VASSPID-48) in patients with acute pain.

Iroko Pharmaceuticals president and CEO John Vavricka said, "Data from this study, together with positive results announced earlier this year from our Phase 3 study of lower dose submicron diclofenac in acute pain, add further momentum to Iroko’s goal of leading meaningful progress in this underserved therapeutic area."